Alexander C Fanaroff1, Stefan K James2, Giora Weisz3, Kristi Prather4, Kevin J Anstrom4, Daniel B Mark1, Ori Ben-Yehuda5, Karen P Alexander6, Gregg W Stone7, E Magnus Ohman1. 1. Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 2. Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden. 3. Division of Cardiology, Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. 4. Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. 5. Cardiovascular Research Foundation, New York, New York. 6. Department of Medicine, Division of Cardiology, Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. Electronic address: karen.alexander@duke.edu. 7. Division of Cardiology, Columbia University, New York, New York; Cardiovascular Research Foundation, New York, New York.
Abstract
BACKGROUND: Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES: This study sought to examine ranolazine's antianginal effect in relation to glucose control. METHODS: The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-up. Interaction between baseline HbA1c and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested. RESULTS: Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42 ± 0.08% (adjusted mean difference ± SE) and 0.44 ± 0.08% from baseline to 6 and 12 months, respectively, in DM patients, and by 0.19 ± 0.02% and 0.20 ± 0.02% at 6 and 12 months, respectively, in non-DM patients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DM patients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baselineHbA1c ≥7.5% than those with HbA1c <7.5% (interaction p = 0.07). CONCLUSIONS: In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA1c, but the effect on angina dissipated by 12 months.
RCT Entities:
BACKGROUND:Chronic angina is more common in patients with diabetes mellitus (DM) with poor glucose control. Ranolazine both treats chronic angina and improves glucose control. OBJECTIVES: This study sought to examine ranolazine's antianginal effect in relation to glucose control. METHODS: The authors performed a secondary analysis of the RIVER-PCI (Ranolazine in Patients with Incomplete Revascularization after Percutaneous Coronary Intervention) trial, a clinical trial in which 2,604 patients with chronic angina and incomplete revascularization following percutaneous coronary intervention were randomized to ranolazine versus placebo. Mixed-effects models were used to compare the effects of ranolazine versus placebo on glycosylated hemoglobin (HbA1c) at 6- and 12-month follow-up. Interaction between baseline HbA1c and ranolazine's effect on Seattle Angina Questionnaire angina frequency at 6 and 12 months was tested. RESULTS: Overall, 961 patients (36.9%) had DM at baseline. Compared with placebo, ranolazine significantly decreased HbA1c by 0.42 ± 0.08% (adjusted mean difference ± SE) and 0.44 ± 0.08% from baseline to 6 and 12 months, respectively, in DMpatients, and by 0.19 ± 0.02% and 0.20 ± 0.02% at 6 and 12 months, respectively, in non-DMpatients. Compared with placebo, ranolazine significantly reduced Seattle Angina Questionnaire angina frequency at 6 months among DMpatients but not at 12 months. The reductions in angina frequency were numerically greater among patients with baseline HbA1c ≥7.5% than those with HbA1c <7.5% (interaction p = 0.07). CONCLUSIONS: In patients with DM and chronic angina with incomplete revascularization after percutaneous coronary intervention, ranolazine's effect on glucose control and angina at 6 months was proportionate to baseline HbA1c, but the effect on angina dissipated by 12 months.
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